MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO DYNAMICS 9.X; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number 10090370

Device Problems Use of Device Problem (1670); Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019 per the potential complaint report, there was no injury associated with this issue.No data mixup or loss occurred which would result in the need for a patient rescan.Customer changed the archive settings in source manager due to which studies have been getting deleted from cache.Customer understands data loss was due to this misconfiguration.This issue has been addressed at the site, therefore no new data loss has occurred.The risk to the customer / patients at the site from the product is evaluated as none.The product documentation did not contribute to the misconfiguration.The risk to the customer / patients from the data loss is evaluated as low as the clinical study reports for the lost images are still available.The syngo dynamics system did not cause or contribute to the loss of data.The system is working as specified.

Event Description

A data loss of approximately 200 clinical image studies while archiving was reported from a site.Siemens factory experts evaluated the reported issue and found that user actions caused the data loss and that the data loss was unrecoverable.The historical images are no longer available for comparison with newer images however the clinical reports generated from the read of the studies prior to archival are still present.There are no injuries attributed to this event.

• Brand Name: SYNGO DYNAMICS 9.X
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 8544683
• MDR Text Key: 161428529
• Report Number: 3002808157-2017-71316
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10090370
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other